Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216063
Company: LUPIN LTD
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOLVAPTAN | TOLVAPTAN | 15MG | TABLET;ORAL | Prescription | AB2 | No | No |
| TOLVAPTAN | TOLVAPTAN | 30MG | TABLET;ORAL | Prescription | AB2 | No | No |
| TOLVAPTAN | TOLVAPTAN | 45MG | TABLET;ORAL | Prescription | AB | No | No |
| TOLVAPTAN | TOLVAPTAN | 60MG | TABLET;ORAL | Prescription | AB2 | No | No |
| TOLVAPTAN | TOLVAPTAN | 90MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/23/2025 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216063Orig1s000TAltr.pdf |
TOLVAPTAN
TABLET;ORAL; 15MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JYNARQUE | TOLVAPTAN | 15MG | TABLET;ORAL | Prescription | Yes | AB2 | 204441 | OTSUKA |
| TOLVAPTAN | TOLVAPTAN | 15MG | TABLET;ORAL | Prescription | No | AB2 | 218381 | APOTEX |
| TOLVAPTAN | TOLVAPTAN | 15MG | TABLET;ORAL | Prescription | No | AB2 | 216063 | LUPIN LTD |
TABLET;ORAL; 30MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JYNARQUE | TOLVAPTAN | 30MG | TABLET;ORAL | Prescription | Yes | AB2 | 204441 | OTSUKA |
| TOLVAPTAN | TOLVAPTAN | 30MG | TABLET;ORAL | Prescription | No | AB2 | 218381 | APOTEX |
| TOLVAPTAN | TOLVAPTAN | 30MG | TABLET;ORAL | Prescription | No | AB2 | 216063 | LUPIN LTD |
TABLET;ORAL; 45MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JYNARQUE | TOLVAPTAN | 45MG | TABLET;ORAL | Prescription | Yes | AB | 204441 | OTSUKA |
| TOLVAPTAN | TOLVAPTAN | 45MG | TABLET;ORAL | Prescription | No | AB | 218381 | APOTEX |
| TOLVAPTAN | TOLVAPTAN | 45MG | TABLET;ORAL | Prescription | No | AB | 216063 | LUPIN LTD |
TABLET;ORAL; 60MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JYNARQUE | TOLVAPTAN | 60MG | TABLET;ORAL | Prescription | Yes | AB2 | 204441 | OTSUKA |
| TOLVAPTAN | TOLVAPTAN | 60MG | TABLET;ORAL | Prescription | No | AB2 | 218381 | APOTEX |
| TOLVAPTAN | TOLVAPTAN | 60MG | TABLET;ORAL | Prescription | No | AB2 | 216063 | LUPIN LTD |
TABLET;ORAL; 90MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JYNARQUE | TOLVAPTAN | 90MG | TABLET;ORAL | Prescription | Yes | AB | 204441 | OTSUKA |
| TOLVAPTAN | TOLVAPTAN | 90MG | TABLET;ORAL | Prescription | No | AB | 218381 | APOTEX |
| TOLVAPTAN | TOLVAPTAN | 90MG | TABLET;ORAL | Prescription | No | AB | 216063 | LUPIN LTD |